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QSYMIA Drug Profile
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When do Qsymia patents expire, and when can generic versions of Qsymia launch?
Qsymia is a drug marketed by Vivus and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.
This drug has sixty-four patent family members in nineteen countries.
The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.
US ANDA Litigation and Generic Entry Outlook for Qsymia
Qsymia was eligible for patent challenges on December 31, 1968.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 14, 2020. This may change due to patent challenges or generic licensing.
There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for QSYMIA
| International Patents: | 64 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 9 |
| Patent Applications: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for QSYMIA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for QSYMIA |
| DailyMed Link: | QSYMIA at DailyMed |
Generic Entry Opportunity Date for QSYMIA
Generic Entry Date for QSYMIA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE, EXTENDED RELEASE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for QSYMIA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| AstraZeneca | Phase 3 |
| Woman's | Phase 3 |
| Lindner Center of HOPE | Phase 2 |
Recent Litigation for QSYMIA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| VIVUS, INC. v. TEVA PHARMACEUTICALS USA, INC. | 2015-04-15 |
| VIVUS, INC. v. ACTAVIS LABORATORIES FL, INC. | 2014-06-12 |
Pharmacology for QSYMIA
| Drug Class | Sympathomimetic Amine Anorectic |
| Mechanism of Action | Cytochrome P450 3A4 Inducers Cytochrome P450 2C19 Inhibitors |
| Physiological Effect | Appetite Suppression Increased Sympathetic Activity Decreased Central Nervous System Disorganized Electrical Activity |
Synonyms for QSYMIA
| 960078-81-3 |
| Phentermine / topiramate |
| Phentermine and topiramate |
| Phentermine mixture with topiramate |
| Phentermine Topiramate |
| PWDLDBWXTVILPC-WGAVTJJLSA-N |
| Qnexa |
| Qsiva |
| Topiramate / Phentermine |
| VI 0521 |
| VI-0521 |
Paragraph IV (Patent) Challenges for QSYMIA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| QSYMIA | CAPSULE, EXTENDED RELEASE;ORAL | phentermine hydrochloride; topiramate | 022580 | 2013-07-18 |
US Patents and Regulatory Information for QSYMIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-004 | Jul 17, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-003 | Jul 17, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-004 | Jul 17, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-003 | Jul 17, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-001 | Jul 17, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-002 | Jul 17, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-003 | Jul 17, 2012 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for QSYMIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-001 | Jul 17, 2012 | Start Trial | Start Trial |
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-003 | Jul 17, 2012 | Start Trial | Start Trial |
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-004 | Jul 17, 2012 | Start Trial | Start Trial |
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-002 | Jul 17, 2012 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for QSYMIA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2305228 | Start Trial |
| European Patent Office | 2317997 | Start Trial |
| European Patent Office | 2305226 | Start Trial |
| Hong Kong | 1213489 | Start Trial |
| Israel | 209875 | Start Trial |
| China | 102112126 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0076493 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
